FDA Adverse Event
Injury
Summary report: N
INCORE LAPIDUS
MDR report key: 11633628
·
Received April 8, 2021
Report
- Report Number
- 3009540749-2021-00008
- Event Type
- Injury
- Date Received
- April 8, 2021
- Date of Event
- March 10, 2021
- Report Date
- April 7, 2021
- Manufacturer
- NEXTREMITY SOLUTIONS
- Product Code
- HWC
- PMA / PMN Number
- K190231
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED DURING A SURGERY INVOLVING THE LAPIDUS INCORE DISPOSABLE KIT 28L ON (B)(6) 2021 THAT THE POST ASSEMBLY WAS IN THE INCORRECT ORIENTATION. THE SURGEON OPENED A NEW POST IMPLANT TO COMPLETE THE PROCEDURE, RESULTING IN A 30 MIN DELAY .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 530864 | INCORE LAPIDUS | SCREW | HWC | NEXTREMITY SOLUTIONS | 168B29619A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |